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RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome

NCT02386423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-03-11

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap that produces adjustable targeted pressure on specific muscles in the feet, to reduce the symptoms of moderate to severe primary Restless Legs Syndrome.

Conditions

  • Restless Leg Syndrome

Interventions

DEVICE

RESTIFFIC™ Brand Pressure Application System

The device, RESTIFFIC™, was administered intermittently through the course of the study: one-week baseline period without the device (days 1-7), three weeks of initial testing with the device (days 8-28), a subsequent one-week period without the device (days 29-35), and three weeks of subsequent testing with the device (days 36-56).

Sponsors & Collaborators

  • Lake Erie Research Institute

    lead OTHER

Principal Investigators

  • Phyllis J Kuhn, PhD · Lake Erie Research Institute

  • Daniel J Olson, DPM, AACFAS · Baycity Associates in Podiatry Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-04-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02386423 on ClinicalTrials.gov